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临床试验/NCT00251342
NCT00251342Unknown2 期

Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
2 期
入组人数
460
试验地点
1
主要终点
Mother's mental health at 6 months postpartum, as measured on the EPDS and General Health Questionnaire-12 (GHQ-12), both being self-report questionnaires.

研究概览

简要总结

The objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical practice (usual practice), using randomized controlled trial design. With the use of the EPDS for the screening of postnatal depression, it is expected that more mothers in need of intervention (including mental health intervention, guidance in childcare and parenting, counseling in family relationships, etc) will be picked up and offered appropriate intervention, compared to the usual practice. It is hypothesized that the mental health of the group of women under the EPDS screening programme will be better than those under the usual practice, on subsequent follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double

入排标准

性别
Female
接受健康志愿者

入选标准

  • Chinese mothers of newborn babies <= 2 months who are registered with the 4 Maternal and Child Health Centres under study;
  • Normally resident in Hong Kong (Hong Kong ID card holder, or HK Birth Certificate [with status of permanent resident indicated established] holder, or people who have been granted unconditional stay in Hong Kong, or passport holders having valid travel document showing the right to land in Hong Kong, or permission to land, or eligibility of HK permanent ID card verified, or entitlement to the right of abode in HK)

排除标准

  • Those who do not use the Chinese language (in both the written and spoken form);
  • Those who are under active psychiatric contact;
  • Those who delivered in hospitals which are still conducting their own EPDS screening programme.

结局指标

主要结局

Mother's mental health at 6 months postpartum, as measured on the EPDS and General Health Questionnaire-12 (GHQ-12), both being self-report questionnaires.

次要结局

  • Mother's parenting stress (measured by the Parenting Stress Index, a self-report questionnaire)
  • Marital relationship satisfaction (measured by the Chinese Kansas Marital Satisfaction Scale, a self-report questionnaire)
  • Marital status and employment status (both father and mother, where applicable) at 6 and 18 months postpartum
  • Child health measures, including weight at 6 and 18 months, number of hospitalizations and visits to doctors within the first 6 and 18 months as reported by mother
  • Mother's mental health outcome (EPDS and GHQ scores) at 18 months postpartum

研究者

申办方类型
Other

研究点 (1)

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